Intrauterine device as method of contraception

Dr. Rosca Augustin
First University Hospital of Obstetrics and Gynecology, University of Medicine, Cluj-Napoca, Romania

1. HISTORY

Is known from antiquity what a foreign body inserted in the uterus have contraceptive effect. In those times were used semi-precious stones polished before.

The modern era of the IUDs start in l909 when Richard Richter in Germany used as intrauterine device a ring from silkworm gut. This invention had no medical interest at those times. The problem was studied also by Ernst Graefenberg in l929; the results of his experiments have started a strong controversy on the problem of the induction of the PID and the European practitioners rejected the idea. Most lucky, in Japan in 1934 Tenrey Ota presented the results of his studies on the use of elastic metallic rings as IUDs. The idea was accepted and the IUDs used at high rate. Also, during the World War II, this contraceptive method was imposed in the occupied territories in Asia. This is one of reasons for the high rate of use of the IUDs in Asia.

After 1950 the opinion about the IUDs changes also in Europe after the results of studies of Oppenheimer in Israel and Ishihama in Japan. The experiments and the studies have finally provided the first IUDs on the market in 60`s. The last decades have brought few news-the shape of T and the addition of Cooper and the hormone releasing.

2. WORLD WIDE USE

In 90`s were using the IUD more than 85 million women worldwide. The most important user is China using 70% from the world IUDs production and this means over 72 millions of women in 1990.In China almost 3o% of married women of reproductive age are using IUDs, the method is used by the couples more than the surgical sterilisation for his reversibility. How we know the one child campaign is the official demographic policy in China and the IUD is the favoured method of contraception.

In India the use of the IUDs has become to increase, in 1985 4% of the Indian women of reproductive age were using them. For the rest of the world the situation in the 90`s was:

Europe	13%
USA and Canada	5%
Australia and New Zealand	5%
Japan	4%
Latin America and Caribbean	4%
Other Asian countries	6%

Having a general view, the IUD is used:

by 3% of married women of reproductive age in China
by 3% of married women of reproductive age in developing countries.
by 7% of married women of reproductive age in developed countries
by 4% of the women over the world except China
by 10% of all women of reproductive age over the world.

3. EFFECTIVENESS

The IUD is one of the most effective methods of contraception, with most devices the pregnancy rate range from 1 to 3 per 100 women per year. The pregnancy rate was higher in inert IUDs-3% but quickly decreased with the appearance of the newer copper IUDs. The Copper 7 and Copper T 200 have failure rates above 2 per l00 women per year. The Nova T and Multiload 250 have the failure rate of less than 1,5 per 100 and the new copper devices TCu 220C,TCu 380 Ag, TCu 380 A and Multiload 375 have the lowest rate-less than 1% at one year. The new generation of steroid releasing devices had at the beginning-at Progestasert the failure rate was 2,9 per 100 women/year but the Levonorgestrel releasing devices have the failure rate of less than 2% and the last types less than1% per 100 women/year. For all devices the rates of pregnancy and removal tend to fall slowly with time after insertion. The expulsion rate falls also with time. The overall failure rate is low for all current devices, in the range of 0,3-2,0/100 women years, including pregnancies which are due to unrecognised expulsions estimated at about one-third of the total in the first year.

Duration of use: the inert devices may be used to menopause and need not to be removed until then, except for specific indications. All copper devices have been shown to remain effective for at least four years and some are effective for 8 years or more (TCu-380 A). The only currently available hormone releasing devices must be replaced every year and longer-lasting hormone devices are under development (Lng Nova T)

4. SPECIFIC ROMANIAN SITUATION

During the fallen regime, contraceptive and sexual education was generally unavailable and importation and sale of contraceptives was forbidden. The women had knowledge about IUDs and have illegally brought them from Hungary and Soviet Union. The gynaecologists knows how to insert IUDs and have inserted them; the interdiction for the IUD's insertion was made only in l986, but this don't means what the use of this contraceptive method was stopped.

After the start of an official contraceptive programme in 90`s the IUD have become quickly one of the favourite contraceptive method. After the information of the "Reproductive health survey-Romania l993 " of the Ministry of Health:

70% from the population sample of this study knows the IUD, second after the condom.
57,3% are using contraceptive methods
4,3% are using IUDs and this is the favourite modern method before condom (4,1%) and pills (3,2%).
The IUD is prevalently used in the northern part of Romania in Transylvania (6,5%) before Bucharest (5,8%) and 1,8% in Moldavia.
The IUD is prevalently used by the multipara women-17% versus 0,6% in nullipara women. As types of IUD in my centre and in my region-Transylvania we are prevalently using the Copper T380A, the Multiload, Copper T 250 and more seldom other models.

5. DIFFERENT TYPES OF IUD

During the modern history of the IUDs they have two distinct periods.

1. The inert IUDs period

The first of them, since 1960 are represented by Lippes Loop and the Margulies spiral. Between them the Lippes Loop have made career; made from polyethylene, with barium sulphate added for the visibility on X-rays, is available in four sizes, from A to D. The area of major use-the developing countries except China. The Lippes Loop was first presented by his inventor at the 1-st International Conference on IUDs in New York in 1962 and became the standard inert device; the major studies on the IUD were made using this device. A large range of IUDs types have developed after the Lippes Loop but their use was short and the area of use limited. In the same period are developed in China the flexible stainless steel rings with a single or double coil; this rings are widely used in China.

2. The active medicated IUDs period

The second period is the period of the active IUDs represented by the types with copper added and later with hormone releasing.

The Copper IUDs have usually the shape of T; the copper is added wrapped around stem. The number added to the T-200, 220,380 etc. shows the surface of the copper in square mm; a larger surface means a higher activity. In 1972 appears on the market the Copper T-200 with the models 200,200B, 200Ag.The areas of major use is world wide except China and USA.

In l974 is marketed first the Multiload 250.This IUD has an original arched shape and the copper is also added on the steam.

In l976 appears the Progestasert-a T shape IUD which have not copper and have in the vertical stem a reservoir of 38 mg progesterone, releasing 65 micro-grams per day.

In 1979 is produced the Nova T which have also T shape but the horizontal wings of T are elastic; in 1980 is marketed first the TCu-220C with copper sleeves-2 on the arms and 5 on the stem. In l982 appears the TCu-380 A, with two 33 sq.mm sleeves on the arms and a 314 sq.mm copper wire on vertical stem. The Tcu 380 A is one of the most used IUDs; the area of major use includes: USA, Finland, Canada, Western Europe and Asia except China. The approved lifespan is today 10 years. This is a short review of the most used IUDs, without to have the pretention to cover all types; I have followed the use in my geographical area.

6. THE MECHANISM OF ACTION

The anti-fertility effect of IUD's is not fully understood; for years some people speculated that biochemical changes in the uterus caused by an IUD destroyed the fertilised ovum or prevent implantation. New studies suggest that IUDs act earlier in the reproductive process and actually prevent sperm from fertilising ovum.

The WHO scientific group on the mechanism of action, safety and efficacy of IUD's (1986) said that is unlikely that one single mechanism of action accounts for the anti-fertility effect of IUD's. Here seems to act together:

A foreign body reaction in the endometrium which is potentiated by addition of copper, with increased number of leukocytes, all the different types of white cells involved in a typical foreign body reaction are represented.
Has also been reported phagocytosis of the sperm-the number of the spermatozoa reaching the upper genital tract are fewer in IUD users.
Studies (Chile) shows what none of the ova recovered from IUD users have clear signs of fertilisation and normal embryonic development in contrast with non users. All of the women from this study had recently sexual intercourse around the time of the ovulation. Is evident what IUDs generally work by preventing fertilisation.
Studies using assays for hCG secreted by the cells surrounding the fertilised ovum, have found hCG indicating fertilisation in less then one per cent of the menstrual cycles in copper IUD users.
As result of foreign body inflammatory response in the uterus the concentration of various types of white cells, prostaglandin and enzymes in uterine and tuba fluids increased markedly especially with copper IUDs. This changes may interfere with transport of sperm in the genital tract, may damage sperm and ova so that fertilisation is impossible. In most studies fewer sperm are found in the fallopian tubes in IUD users as in non-users. Other sperm may be damaged or consumed by the various types of white blood cells.
Copper enhances the foreign body reaction in the endometrium and affects endometrial enzymes, glycogen metabolism and oestrogen uptake and may inhibit sperm transport.
The steroid releasing IUDs supplies the endometrium in a way similar to progestin-only pills and inhibits ovulation.

7. INDICATIONS OF USE

By tradition the IUD is first indicated for parous women who don't wish to take oral contraception or in woman in whom their use is contraindicated.

Nullipara women unable to use another form of contraception. The legend of the contraindication of the IUD's in the nullipara women is based on the traditional opinion what in this women the IUD will be treated as a foreign body by the uterus which will expulse it; the uterus of the parous women is not so reactive having the experience of a pregnancy. In this idea there are a lot of IUDs having different sizes, including little especially for nullipara women.
The forgetful women, especially after the experience of unwanted pregnancies forgetting the pill. Once inserted the IUD cannot be forgetted and the contraceptive protection is sure.
Women coming of the pill and who don't want another method including sterilisation, usually belonging to the over 35-40 years group.
Women which have not frequent intercourse or see their partners sporadically.
Practically the IUD can be used upon request if the women haven't contraindications.

8. CONTRAINDICATIONS

Like other contraceptive methods the IUDs are not indicated for all women at all times. The contraindications are absolute and relative.

ABSOLUTE CONTRAINDICATIONS.

Acute or chronic pelvic inflammatory disease (PID). The practice has shown us what in the presence of any form of PID the IUD is not indicated. In the acute form his presence will increase the severity of infection; in the chronic forms or in the recent passed acute infections in the history of the patient, the foreign body reaction can reactivate the PID.
Known or suspected pregnancy-in this situations we must wait for the end of the pregnancy by birth or termination, and only after to reconsiderate the opportunity of the IUD's use.
Undiagnosed abnormal vaginal bleeding which must be diagnosed and treated before the IUD's insertion.
Confirmed or suspected malignancy of the genital tract.
Copper allergy or Wilson's disease-for the copper IUDs only.

RELATIVE CONTRAINDICATIONS.

Previous ectopic pregnancy. If the woman has never had a successful pregnancy, is better to choose an alternative contraceptive method.
Vaginal or cervical infections-must be treated before the IUD's insertion for don't propagate ascendently.
Uterine fibroids-if are not large and periods are not excessively heavy the IUD can be inserted.
Abnormalities of the uterine cavity or malformations. Having the HSG of the cavity, we can find a solution but in my opinion is better to use another contraceptive method.
uterine scars from other interventions as the caesarean section
We can also discuss about anaemia, menorrhagia, valvular heart disease, lactation, and corticosteriod treatment etc situations when only the doctor can decide.

9. THE INSERTION OF THE IUD

A. Time of insertion.

The timing of insertion of an IUD can be:

Theoretically the IUD may be inserted at any time during the menstrual cycle but not later than day 19 of a 28 day cycle because the possibility of pregnancy. The insertion during or shortly after a menstrual period is recommended for the next reasons: the pregnancy is excluded, the cervix is soft and the os open, the post-insertion discomfort and the bleeding is less. The disadvantage is the higher rate of expulsion, which is lower in the later insertion; the later insertion has a higher rate of pain and bleeding.
After delivery-is associated with a very high expulsion rate. Different authors used modified IUDs to reduce expulsion in post-partum; they are testing to use a piece of chromic catgut, looped around the T which will be pushed into the wall of the uterus with a needle inserted. Thus the IUD is anchored in place for three to five weeks until the catgut dissolves.
After termination of pregnancy-the rate of expulsion is not increased when an IUD is inserted immediately after termination of first trimester pregnancy.
After spontaneous abortion.
During the caesarean section.
After unprotected intercourse as an emergency method.

B. Technique.

Theoretically we have two basic techniques:

The pushing-out technique-was used especially for the Lippes loop devices. The inserted containing the IUD is introduced through the cervical canal and depassing the internal os, fastening the inserted, the IUD is pushed-out.
The withdrawal method-used for the Copper T`s-the iserter is pushed into the uterine cavity as far as the fundus and then fastening the pusher we retract the insertor`s tube. The T device will regain his usual shape in some minutes.

C. Steps in the IUD insertion

First we must to prepare the instruments. If we haven't a standard IUD insertion kit we need: two valves or a speculum, forceps's for swabs, a holding forceps, an uterine sound, a kidney dish, pots for the sterilising solution, scissors. These instruments are sterilised before, ideally in a central sterile supply department. If the sterilisation of the instruments cannot be assured, we must sterilise them using chemical methods:

IUDs and inserters-30 minutes in iodine solution 1:2500,or 30 min. in 70% alcohol. After sterilisation, before use they will be washed in sterile or boiled water.
The instruments can be boiled for 20-30 minutes in a container or soak for 30 minutes in activated glutaraldehide (or overnight) and washed in sterile or boiled water before use. We will use sterile gloves for the insertion and for the manipulation of the IUD if necessary.
Will perform a bimanual examination of the pelvis to precise the situation of the uterus.
The cervix is exposed with a speculum, is cleansed with antiseptic solution and grasped with the forceps. The forceps stabilises the uterus and help us to achieve correct fundal placement.
A fine uterine sound is passed gently to determine the depth and direction of the uterine cavity and the direction of the cervical canal.
The device is loaded into the introducer using sterile gloves. A lot of IUDs don't need to be introduced in the applicator; they are enough elastic to permit the access in the uterine cavity (Multiload for example)
The introduce tube is carefully inserted through the cervical canal; the IUD released according to the specific instructions of the provider.
To exclude the low position of the IUD is helpful a new sounding of the cervical canal with the uterine sound.
We will cut with the scissors the threads of the IUD to about 3 cm from the external os.
At the end we remove the forceps and the speculum.

1O. THE REMOVAL OF THE IUD

An IUD may be removed if the patient want a pregnancy or changes the contraceptive method or in case of complications. At the menopause the IUD will be removed 12 months after the last menstrual period.

Technique.

A. Visible threads.

The removal of the IUD can be performed at the menstrual period or any time in the cycle.

We perform a bimanual examination of the uterus to check the size and position.
Expose the cervix with a speculum.
The cervix is cleansed with an antiseptic solution.
Will grasp the thread firmly near the cervical external os with the forceps.
Apply a gentle downward traction and the IUD will be extracted.

If will find a resistance, must to use the cervix forceps to help us. Sometimes is necessary to dilate the cervical canal or to administrate local anaesthesia.

B. The threads break

If the threads break after the traction, the stem of the IUD can be in the cervical canal.

Apply the cervix forceps to stabilise the cervix.
With a straight forceps will grasp the lower part of IUD and will extract it. If the procedure fail will proceed as for lost threads.

C. The lost threads.

When threads are not visible at the external os, the device may be into the cavity, embedded in the uterine wall, in the peritoneal cavity or expulsed before first we look for the threads.

Expose the cervix with the speculum in a good light to see the threads. If they are not visible, with a right forceps we can explore the upper cervical canal to find the threads. Also we can apply a gentle suction with a catheter attached to a syringe. This will often bring down the threads.
The threads can be brought down with an IUD removal hook, which can also find the IUD.
If all this procedures fails, it must to have an ultrasonography of the uterus, which will show us the placement of the device. In this situation we are performing a cervical dilatation and an intrauterine exploration with a uterine sound to find the IUD. This will be extracted with a long arm forceps or by curettage.

11. RISK AND BENEFITS

A. The main advantages of the IUDs use are:

Not required any preparation once inserted.
No interference with the spontaneous sexual intercourse.
Visits for medical check-up are infrequent.
More than 7O% of users have not major side effects.
Devices can be left in place for years.
No evidence of increased rate of cervical cancer.

B. Minor risks:

Lower abdominal pain may occur at insertion usually at the nullipara women and last for few days. During the first months after insertion pains can accompany periods but after they are insignificant.
Heavy periods: all devices cause an increase in the amount of bleeding and the length of the period. Knowing what the average loss in a normal cycle is 35 ml, with a copper IUD the loss increased at 50-60 ml and with inert device 70-80 ml.
Menstrual irregularities: are usual intermenstrual bleeding or spotting and gets less with time. Also the pre-menstrual spotting is common.
Discharge: is common in IUD users and is watery or mucoid without pathological significance. If become fetid and unpleasant is the sign of an incipient infection and must be treated.
Expulsion: after the insertion, uterine contractions can push the device downward causing partial or complete expulsion. The expulsion rate varies from less than one to more than 10 at women in the first year of use. The inert IUDs are expelled more often than copper devices, and between them the Nova T and Multiload are expelled least. The expulsion occurs in the first year and especially in the first trimester after insertion and the expulsion rate decrease with the parity and age.

C. Major risks-complications and side effects.

Perforation of the uterus: occurs in about 1 at 1000 cases during the IUD's insertion and involve the uterine fundus or the cervix. Perforation may be partial with just part of the IUD piercing the uterine wall or complete passing through the uterus into the abdominal cavity. Perforation may go unnoticed at the time of insertion and the uterine fundus heals quickly without treatment. Devices should be removed from the abdominal cavity because they can cause an inflammatory reaction and adhesions especially the copper IUDs and hormone releasing types. The inert IUDs can be abandoned in the cavity and removed only if the woman has abdominal symptoms (IPPF 1987) but using the laparoscopic way. The removal is very easy and the woman has not risk of inflammatory reactions.
Bleeding: is usually present after the insertion of an IUD as intermenstrual bleeding or spotting. The amount of bleeding is not a medical indication for removal of the device only if continues for more than 8 to10 weeks. Of course if the bleeding is of any severity causing anaemia the device must be removed. There were a lot of treatments-anti-inflammatory drugs, amino-caproic acid, calcium, ergotate, ascorbic acid, K vitamin, progestagens in the second part of the cycle but none entirely satisfactory.
Pain: may occur soon after fitting usually in the form of uterine cramps. The pain or discomfort is rarely present for more than the first weeks after the IUD's application. If pain persist and is associated with significant discharge or bleeding the situation must be re-evaluated. It must also exclude the causes of pain unrelated to the IUD-endometriosis, ovarian cyst etc. Analgesics may be given to some women; severe uterine cramps during the fitting of IUDs are found in nullipara or in the women who have not had a child for some years, and here we can also use the analgesics. If occurs severe pain, which persist for weeks, it must to look for an inflammatory reaction.
Infection: since IUDs were first used, there has been controversy about how much danger exists of associated PID. PID is a broad term for any infection ascending from the cervix into the uterus, fallopian tubes and ovaries. About one to two percent of all women of reproductive age develop PID every year, STD and post-partum and post abortion infections are major causes of PID.

The epidemiological researches in 1970`s and early 80`s tended to overestimate the risk of PID from IUD's use. They reported that the IUD users were up to10 times more likely to develop PID than the other women. Studies performed in the next 10 years have found a lower risk: 1.6 in USA and 2.3 times more likely as the other women in the developing countries (WHO 1984). The treatment of PID involves:

Early diagnosis
Antibiotic therapy.
Removal of the IUD.
Frequent follow -up.
Treatment of the sexual partner in case of STD.

Because we know the treatment of the PID I don't insist on the details.

Pregnancy: the pregnancy rate is between less than 1% and 2% in the IUDs users and when pregnancy occurs two of three are with the device in place. If a pregnancy occurs with a tailed device "in situ " the risk of spontaneous abortion is greater with the device left in place than if is removed. If the tail is not in place and the removal can be performed only with a hook the risk of abortion is less if the device is left in situ. If the pregnancy is not wanted is better to perform an abortion then to wait for a spontaneous one. Other complications in case of the pregnancy at an IUD user are the spontaneous abortion and the premature delivery, but no evidence that the pregnancy is more likely than usual to result in an infant with congenital anomalies.
Ectopic pregnancy: a lot of studies found that the IUD users were 50% less likely to have ectopic pregnancies than women using no contraception but in the same time protect better against intrauterine pregnancy. Also in the IUD users the pregnancy is more likely to be ectopic than in the other women, in IUD users are estimate one in 30 pregnancies or 3 to 4% is ectopic. In the general population one in 125 pregnancies or 0,8% is ectopic.

The higher ratio of ectopic pregnancies in IUD users than in non-users can be explained in two ways:

IUD not prevent ectopic pregnancy as well as they prevent uterine pregnancy
IUD-related inflammation or infection in the tubes interferes with the movement of fertilised ovum making ectopic pregnancy more likely. There is no evidence that either inert or copper bearing devices cause ectopic pregnancies.

12. COUNSELLING AND CLIENT SELECTION

Some women will request an IUD because they wish to have a change from other methods or have heard good reports from friends who have used the IUD for many years without problems. These clients must be informed about other methods of contraception and evaluate if in this particular situation the IUD is indicated or not.

In the case of some other women the choice of an IUD may be dictated by circumstances. This is the case of women who have developed complications while using hormonal contraception or other methods. Also in this cases must be presented all other methods of contraception to assure an informed choice.

All women being selected for the IUD use should be informed about the fitting procedure, the complications and side effects that may occur. Should be mentioned the possibility of the IUD being expelled especially at the time of menstruation or soon after. Is also important to inform the future IUD carrier about the possibility of an ectopic pregnancy and the women should be informed about the signs and symptoms in a situation.

It should be told which type of IUD would be inserted, how long it should remain in the uterus and how this will be removed. The woman should know that it does not protect against STD, included HIV.

13. CHOICE OF IUD

All the IUDs available at present have advantages and disadvantages but there are however certain general points that can be made:

The copper bearing IUDs have been shown to be more safe and effective than the inert types and to have a longer duration of use.
The smaller size IUDs usually cause less menstrual blood loss than the larger ones.
Must consider the IUDs models available, the size and shape of uterus, the age and the parity of the woman.
It is very well to use the patient's card finded into the package of the device because this will note for other colleagues and us the date of insertion, the type of IUD, helpful at the removal.
In general it is better to fit the IUD type for which the inserted person has skill and experience.

14. FERTILITY RETURN AFTER IUD USE

Most women who discontinue IUD's use to become pregnant conceive as quickly as non-users. The opinion of different authors are that IUD does however increase the risk of developing PID and sometimes this leads to tuba infertility.

US case control studies (Cramer-78) report that childless women with tuba infertility were two to three times more likely to have used IUDs then women having the first child. The risk of tuba infertility varied with the type of IUD and with the number of the woman's sexual partners. The copper IUD's users had only slightly greater risk of tuba infertility than women who had never used in contrast with the former Dalkon Shield users, which had the higher relative risk. The women who had only one sexual partner, regardless of the type of IUD used had no risk of tuba infertility; women who had more than one partner had three or four times higher risk, depending on the type of IUD. In contrast, most cohort studies that have followed women who stopped using IUDs have found no indication of impaired fertility. In 10 studies involving about 3800 women, from 72 to 96 percent of them conceived within a year after stopping the IUD use. This rate is in the same range as rates among women who have never used contraception.

One cohort study (Vesseyl983) did involve women who at some time had discontinued IUD use because of complications (pain, bleeding or discharge). These women gave birth at only a slight lower rate than groups of other women who have discontinued IUD or other methods to become pregnant.

The conclusion can be what the IUD's use is not affecting the fertility of the women in a such grade to be considered important and the fertility return after stopping the IUD use is below 12 months.

15. PATIENT INFORMATION

The informative counselling helps the clients make the best choice of a contraceptive method and helps them use the method safely, effectively and with satisfaction.

The counsellors knows well the six elements to family planning counselling (Population Reports-Counselling Guide-1987) what can remember the steps after the word GATHER. These are:

Greet clients.
Ask clients about themselves.
Tell clients about family planning methods.
Help clients choose a method.
Explain how to use.
Return for follow-up.

Without to detail all this steps, the E step-Explain, shows what we must explain how to use the IUD:

When, where, and how it will be inserted
The common side-effects
The slight chance of more serious complications, expulsion or unintended pregnancy.
The warning signs of serious complications.

Also we will give to the client booklets explaining about the IUD's use to be consulted at home.

16. RETURN FOR FOLLOW-UP

After the insertion of an IUD the woman will be informed for the follow-up visits. The first of them will be after 6-8 weeks. She should understand however that she can return at any time if she has problems or want the IUD removed.

The purpose of routine follow-up visit is to:

Reassure the client about any common side effects.
Check that the IUD is in place
Diagnose any complications and start treatment
Remind women of the warning signs of IUD complications.

The pelvic examination should be performed not only to check that the IUD is in place but also to look for signs of pelvic infections. At each visit the patient should be asked about her menstrual pattern, pelvic pain and vaginal discharge. The examination it is useful to be repeated three months after IUD insertion. Annual checks are useful to ensure if the device is in place.

The copper IUDs should be removed every three or five years depending on the approved lifespan; when using medicated device women should be told to return for removal and re-insertion at appropriate times. If the woman have no problems the inert devices do not need to be removed until menopause when the IUD will be removed at 12 months after the last period.

In case of serious complications the provider of the IUD should make arrangements with a referral medical centre staffed with gynaecologists and having facilities for diagnosis and surgical procedures.

17. FUTURE DEVELOPMENTS

At the day there are two news on the IUD's market: the Flexi Gard and the Levonorgestrel IUD 2O

The Flexi Gard.(Cu Fix 390)

Is known as the Cu Fix 390 and is the result of the Belgian researchers (Dirk Wildemeersch). This consist from a single filament of nylon bearing 6 copper bands as the Copper T-380.At the superior end have a knot and a little loop which is inserted 1 cm into the myometrium by a special stilet. The first results are good - no extra insertion pain, no inflammatory reactions, no increase dysmenorrhea pain, the bleedings are similar as in the other copper IUDs. The pregnancy and expulsion rates 0.3 and o.9 at 1 year.

The Cu Fix PP 330.

Is identical to the Flexi Gard except for a small cone of biodegradable plastic at the proximal end of the plastic filament under the inserted loop. This was developed for insertion in the uterus immediately after delivery of the placenta.

The Levonorgestrel IUD 20.

This is a Nova T shaped device which have in its vertical stem a capsule releasing slowly levonorgestrel at a rate of 20 micro-grams per day.

Initial studies have shown it to be highly effective - failure rate o.1 - 0.3/ 100 women-year. Have a very low ectopic pregnancy rate and makes the menses less heavy leading to oligomenorrhea or amenorrhea. No menstrual pain and reduced risk of PID .The lifespan is 7 years and the return of fertility is rapid after removal.

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Edited by Aldo Campana,